Condition category
Infections and Infestations
Date applied
31/01/2008
Date assigned
04/04/2008
Last edited
04/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martin Donnelly

ORCID ID

Contact details

Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L35QA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The main objectives of the study:
1. Assess if bednets can be used as rapid, high coverage control method for malaria in urban areas
2. Investigate the effect of ITN introduction on malaria, anaemia and anthropometric measurements
3. Assess the use of haemoglobin level as a measurement of intervention efficacy by controlling for nutritional and geohelminth confounding factors

Ethics approval

1. Liverpool School of Tropical Medicine, UK, approved on 23 September 2002 (ref: 02:50). Some amendments to the existing clearance were reviewed on the 30 April 2004 with additional approval granted on 3rd June 2004.
2. Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, ethical clearance granted in September 2002

Study design

Non-randomised controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Malaria and anaemia

Intervention

Insecticide treated bednets vs no intervention (Control group received bednets after six months)

It was not possible to randomly allocate children to the two arms of the study as the intervention was community based. The insecticide treated nets were distributed in the intervention community and therefore all children surveyed in that community entered the intervention arm. All households with children under 10 and/or pregnant women in the control community received an insecticide treated nets after six months.

Duration of intervention: 6 months (although the insecticide treated nets remained the property of the study subjects)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The following were assessed at enrolment, 3 and 6 months:
1. Moderate anaemia, provisionally defined as a haemoglobin level <9 g/dl
2. Haemoglobin level as a continuous variable (in g/dl)
3. Density of infection defined as parasitaemia >5,000 parasites/mm3

Secondary outcome measures

No secondary outcome measures

Overall trial start date

20/05/2004

Overall trial end date

17/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Children aged over 1 month and under 10 years

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

600

Participant exclusion criteria

Children with haemoglobin (Hb) <8g/dl who will require iron supplementation

Recruitment start date

20/05/2004

Recruitment end date

17/12/2004

Locations

Countries of recruitment

Ghana

Trial participating centre

Liverpool School of Tropical Medicine
Liverpool
L35QA
United Kingdom

Sponsor information

Organisation

Liverpool School of Tropical Medicine (UK)

Sponsor details

c/o Dr Martin Donnelly
Pembroke Place
Liverpool
L35QA
United Kingdom

Sponsor type

University/education

Website

http://www.liv.ac.uk/lstm/

Funders

Funder type

Government

Funder name

The Department for International Development (DfID) Malaria Knowledge Programme of the Liverpool School of Tropical Medicine (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes